Kornimate/medical-research-clean huggingface dataset:
human microbiome and healthcare associated infections - nursing home dwelling older veterans

Conditions: Human Microbiome

Summary: the purpose of the research is to find out the effect of commonly used topical antibiotics on the bacteria that live in the nose, throat and on the skin of older adults. in addition, the investigators want to determine if these topical antibiotics affect how bacteria are spread in community living centers of the va maryland health care system.


Eligibility criteria:
inclusion criteria: * age 50 years or older. * living in a participating nursing home for at least 80% of the past 3 months- * willing to provide anterior nares, posterior pharynx, skin and throat specimens over the study period. * willing to use intranasal mupirocin and topical chlorhexidine over a five day period. * provide signed and dated informed consent from subject or lar. exclusion criteria: * recent history of mrsa colonization * use of mupirocin nasal ointment in past 3 months * use of topical chlorhexidine in past 3 months * history of an allergic reaction to chlorhexidine or mupirocin

Keywords: intranasal mupirocin topical chlorhexidine
the video system to provide a developmental training guide for preterm infants

Conditions: Premature Infants; Very Low Birth Weight Infants

Summary: this study aimed to establish a systematic developmental training guide protocol for parent-centered early intervention and verify the concept and feasibility of a video system for parent-centered in-home developmental therapy under the monitoring of a therapist. the target group is premature infants under 32 weeks of gestation or very low birth weight infants under 1500 g with brain damage. a single-arm intervention group of 10 people was recruited, and considering a dropout rate of 20%, the total number of participants was calculated to be 12. 1:1 monitoring to provide parent-centered early intervention at home after discharge from the neonatal intensive care unit is conducted twice a week for 30 minutes per session using a video platform (zoom) until the corrected age of 6 months. parents record the developmental training process using a smartphone and transmit it to the therapist, who analyzes the video data to provide new treatment goals and guidelines. feasibility assessment included: 1) exercise diary: number of total and average sessions performed (n) and percentage (%), number of total and average sessions completed (n) and percentage (%) 2) parent questionnaire 3) video analysis: periodic video education and developmental training video acquisition and analysis 4) heart rate analysis: analysis of average heart rate during and after rest and developmental training 5) safety analysis: number of times (n) and reasons for exercise interruption during developmental training 6) developmental assessment: implementation of developmental assessments such as gmos, mos-r, hine, gmfm, and bsid. for safety assessment, if the following symptoms appear during development training, stop exercising and rest until stable. if oxygen saturation drops by more than 10% compared to resting, causing cyanosis and dyspnea, or if heart rate increases by more than 150 beats/min.


Eligibility criteria:
inclusion criteria: * premature infants less than 32 weeks of gestation or extremely low birth weight infants less than 1500 g * premature infants with a corrected age of less than 1 month * brain damage through brain imaging (e.g. cranial usg, brain mri) exclusion criteria: * multiple malformations or genetic abnormalities * severe visual or hearing impairment * loss of consciousness * tracheostomy * medically unstable condition

Keywords: developmental training premature infants very low birth weight infants early intervention
a study of the safety and efficacy of sk-0503 for diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.


Eligibility criteria:
inclusion criteria: * diabetic macular edema * criteria for visual acuity and macular thickness are met exclusion criteria: * history of glaucoma * known steroid-responder * use of systemic steroids * use of warfarin/heparin * other protocol-defined exclusion criteria may apply

Keywords: eye diseases diabetic eye problems
appi-cost trial for perforated appendicitis

Conditions: Perforated Appendicitis

Summary: the purpose of this study to assess the clinical effectiveness and cost-effectiveness of povidone-iodine (pvi) irrigation in perforated appendicitis, to investigate barriers and facilitators to future implementation of pvi irrigation, and to collect costs and clinical and patient-reported outcomes among patients with non-perforated appendicitis.


Eligibility criteria:
eligibility for enrollment inclusion criteria: * plan to undergo appendectomy for acute appendicitis exclusion criteria: * preoperative hemodynamic instability requiring ongoing infusion of vasopressors * allergy to iodine * uncontrolled hyper- or hypothyroidism * renal dysfunction * pregnant or breastfeeding * primary language neither english nor spanish * lack of functioning telephone or email account * incarcerated or in police custody eligibility for randomization inclusion criteria: * enrolled in study preoperatively * intraoperative diagnosis of perforated appendicitis exclusion criteria: * non-perforated appendicitis

Keywords: perforated appendicitis povidone iodine cost effectiveness intra-abdominal abscess appendectomy implementation science
efficacy of intramuscular naloxone 0.4mg. in prophylaxis of intrathecal morphine induced pruritus after cesarean section

Conditions: Morphine Adverse Reaction

Summary: the purpose of this study is to determine whether intramuscular naloxone 0.4mg. is effective in prophylaxis of intrathecal morphine induced pruritus after cesarean section.


Eligibility criteria:
inclusion criteria: * patient schedule for cesarean section asa class 1 exclusion criteria: * have contraindication for spinal block * complicated pregnancy * have history of drug abuse during pregnancy * obesity bmi\>35kg./m2

Keywords: pruritus intrathecal morphine
safety followup study of cardiovascular events in subjects who participated in selected torcetrapib/atorvastatin studies

Conditions: Cardiovascular Disease; Cerebrovascular Disorders

Summary: an observational safety follow up trial will be conducted to monitor the occurrence of cardiovascular events and all cause mortality in subjects who participated in selected torcetrapib/atorvastatin phase 1, 2, and 3 clinical trials. no hypotheses will be tested.

study a5091075, an observational study in subjects who had previously been treated with torcetrapib, was terminated on 20 dec 2007. the study was terminated following reviews of final safety information from prior torcetrapib studies and the low participation rates observed during the recruitment period for study a5091075 . on the basis of this new information the sponsor determined that it was unlikely that this study would result in new and scientifically valid information.

Eligibility criteria:
inclusion criteria: * have signed informed consent prior to the initiation of any study-specific activities. * have participated in selected torcetrapib/atorvastatin phase 1, 2, and 3 clinical trials and were treated with randomized study medication. exclusion criteria: * there are no exclusion criteria.
therapeutic plasma exchange in the treatment of sepsis associated multi-organ failure [samof-tpe]

Conditions: Sepsis

Summary: the investigators prospective, randomized adult clinical trial investigates the therapeutic efficacy of early therapeutic plasma exchange as adjunct treatment to standard therapy in patients with refractory septic shock and multiple organ failure.


Eligibility criteria:
inclusion criteria: * adult patients are eligible for inclusion if they have sepsis with refractory shock and evidence of organ failure. exclusion criteria: * persons who are pregnant * persons who are incarcerated * acute surgical catastrophe without potential for intervention or source control * cardiac arrest with unknown neurologic status, including patients being treated with therapeutic hypothermia * presence of severe acute brain injury or severe dementia * cardiogenic, neurogenic, obstructive, or post-cardiotomy shock * acute pancreatitis with no established source of infection * diabetic ketoacidosis as primary pathology * note: septic patients who develop dka are eligible for inclusion. however, patients in whom organ dysfunction and hemodynamic instability are due primarily to volume depletion and acidosis from dka should not be included. * need for mechanical circulatory support * prolonged acute illness with \> 24 hours of pressor needs at enrollment and/or end organ damage with further care deemed to be "futile." * note: the time resets if a new inciting event leads to samof. * for example, if a patient has sepsis stabilized but requires operative intervention for source control within the initial 24 hours of admission and returns to the icu with samof, the patient is again eligible for randomization for the next 24 hours. * bedbound state or poor baseline functional status with ecog performance status score ≥ 3 * underlying terminal illness/malignancy with \< 6 months life expectancy * advanced chronic liver disease/cirrhosis with evidence of portal hypertension * asplenia * hiv with harrt non-compliance
sleep deprivation's regulation of immune system function and behavior

Conditions: Sleep Deprivation; Sleep

Summary: the study proposes to investigate whether sleep deprivation will affect a variety of measures, including hormones, immune system functioning, and behaviors related to food intake and hunger. it is predicted that sleep deprivation will affect circulating neutrophil activity, and do so via affects on dna methylation. it is also predicted that sleep deprivation will up-regulate ghrelin, and down-regulate circulating oxytocin. finally, it is predicted that sleep deprivation will increase participants' tendencies to pick larger portions of food, and also increase their tendency to purchase foods that are more caloric in a mock supermarket scenario.


Eligibility criteria:
inclusion criteria: * male * age 18-35y * healthy (self-reported) and not on medication * non-smoking * normal sleep-wake rhythm (i.e. 7-8 h per night, self-reported) exclusion criteria: * major illness * taking any serious medications * any sleep conditions (e.g. irregular bedtimes, sleep complaints) * any dietary issues with the food items provided * a history of endocrine or psychiatric disorders
to test a payer/treatment agency intervention to increase use of buprenorphine

Conditions: Addiction

Summary: a team of researchers from the university of wisconsin-madison college of engineering and oregon health \& science university will test whether clinician training and the use of organizational change strategies are sufficient for disseminating an evidence-based practice (ebp), or if changes to both organizational systems and payer policy results in greater ebp use. demonstrating the role of payment policy as a driver in the adoption of evidence-based practices could provide a contribution to dissemination and implementation science. this study will employ an intervention that was developed through the robert wood johnson foundation-funded advancing recovery (ar) program. in ar, payer/treatment organization partnerships in 12 states collaborated to remove systemic barriers to the adoption of ebps such as medication-assisted treatment for substance abuse disorders. the resulting "ar framework" of payer and organizational change strategies will be tested against its ability to increase the use of the addiction medication buprenorphine as compared to organizational change strategies alone. buprenorphine is an ebp for treating people addicted to heroin or opioid-based pain medications for non-medical use. buprenorphine has experienced low adoption rates and is not a standard part of addiction treatment. in ohio, the location of the study, deaths to due to accidental overdoses of opioids has increased by 304% over the past decade and surpassed auto accidents as the leading cause of accidental deaths in 2006. ohio was selected for the study because of the public health significance of opioid abuse and because each county in ohio acts as a stand-alone payer, offering 48 unique eligible payer environments. this trial will develop a deeper understanding of the role payers and treatment organizations play in implementing and disseminating ebps and will focus on the public health issue of rising opioid abuse.

buprenorphine (ebp) use data will be collected from november, 2012 to may, 2016 through administrative databases located at the state of ohio. participants will be followed for the duration of buprenorphine use that is an average of 5-7 months. organizational and payer data will be collected from january, 2013 to january, 2015. the data from the study will be analyzed and reported during january 2015 to february 2017.

Eligibility criteria:
inclusion criteria: * treatment agencies with greater than 75 admissions per year exclusion criteria: -

Keywords: addiction treatment
combination of venetoclax, hypomethylation agent and low-dose cytarabine as a salvage therapy for acute myeloid leukemia

Conditions: Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Minimal Residual Disease

Summary: although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. in this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

although the promising activity of venetoclax-based therapy is well demonstrated in the treatment of previously untreated elderly or unfit patients with acute myeloid leukemia, there are few data on the efficacy of venetoclax-based salvage therapy in relapsed/refractory patients, which can be difficult to treat. to date, data on venetoclax as monotherapy or in combination with hypomethylation agent or low-dose cytarabine as a salvage regimen in relapsed/refractory aml are scarce and heterogenous. in this study, the investigators aimed to assess safety and efficiency of a new triple-drug combination regimen, venetoclax + hypomethylation agent + low-dose cytarabine, in patients with relapsed/refractory acute myeloid leukemia or persistent positive minimal residual disease in the salvage setting.

Eligibility criteria:
inclusion criteria: 1. aged ≥18 years old, voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures. 2. the toxic and side effects caused by the last treatment should be recovered. 3. eastern cooperative oncology group score of 0 to 3 points. 4. the organ function is intact. * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5×uln (upper limit of normal). * creatinine≤1.5×uln. * bilirubin≤1.5×uln. 5. karnofsky≥70. 6. the expected survival period is at least 12 weeks. 7. non-pregnant, non-breastfeeding women. exclusion criteria: 1. suffering from other untreated or unrelieved malignant tumors within 2 years. 2. major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication. 3. suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure new york heart association \[nyha\] class iii or iv, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial. 4. patients who are unwilling or unable to comply with the protocol. 5. currently being treated with other systemic anti-tumor or anti-tumor research drugs. 6. women who are pregnant or breastfeeding.

Keywords: venetoclax hypomethylation agent cytarabine
pilot study on a health promotion intervention for ultra-orthodox mothers of children with adhd

Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)

Summary: the goal of this study is to evaluate the feasibility and effectiveness of a health promotion intervention for ultra-orthodox jewish mothers of children with adhd. this study will examine the impact of a culturally tailored group-based intervention aimed at reducing stress, enhancing health, and improving the well-being of mothers. the main questions this study aims to answer are: 1. is the intervention feasible for mothers to participate? 2. does the intervention improve maternal knowledge about adhd and reduce stigma? 3. does it help reduce maternal stress and enhance self-care practices? participants include: mothers: ultra-orthodox jewish mothers with a child (ages 6-12) diagnosed with adhd and no other major health conditions in the family (other than adhd). educators: school educators with at least 5 years of experience teaching children with adhd in the ultra-orthodox community. what participation involves: mothers will attend six weekly teletherapy group sessions, with 6-8 mothers per group. they will complete questionnaires before and after the intervention (approximately 30 minutes each) and participate in a 90-minute remote focus group to provide feedback on the program. educators will attend a single teletherapy group session (90 minutes) during the program (session 5) and participate in a 90-minute remote interview to provide feedback on the program.

after providing informed consent, mothers will complete questionnaires which will take approximately 30 minutes before beginning the program. mothers will then be assigned non-randomly to the intervention or control group. mothers assigned to the control group will receive the intervention after the completion of the first intervention group (delayed). the six sessions of the intervention will be teletherapy and each session will be one and a half hours in length. each group will consist of 6-8 mothers per group. inclusion criteria included mothers who identify as ultra-orthodox jewish, have a child between the ages of 6-12 years old who have been diagnosed with adhd by a licensed medical professional, and who do not have any other medical diagnosis. the topics discussed in the intervention will include: awareness/knowledge regarding adhd and its biological origins, identifying resources and optimal treatment for adhd for the child and the mother, strategies for child adhd management in the school, and the legitimacy and importance of maternal self-care.

Eligibility criteria:
inclusion criteria: * mothers of children with adhd aged 6- 12 years old * mothers who identify as ultra-orthodox jews * child diagnosis was by a licensed medical professional exclusion criteria: * child medical diagnosis other than adhd

Keywords: mothering a child with adhd maternal psychological health ultra-orthodox
relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in females with multiple sclerosis

Conditions: Multiple Sclerosis; Menstrual Pain; Anxiety; Fatigue; Neurologic Symptoms

Summary: this study was carried out to investigate the relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in females with multiple sclerosis (fwms). in the neurologic group, especially in ms patients, it is well known that disease activity, course, and symptoms can be influenced by the menstrual cycle. previous studies have reported that the fluctuations of estrogen and progesterone during the menstrual cycle may have an effect on several neurological functions. menstrual-related symptomatology has primarily been studied as a physiological phenomenon. increased neurological symptoms, physical disorders and behavioral changes have been reported just before or at the beginning of menstruation in fwms. for all these reasons,investigators think that relationship between pain, anxiety and fatigue and knee position sense, balance and dual task performance during menstrual cycle in fwms.


Eligibility criteria:
inclusion criteria: the inclusion criteria were as follows: patients with a confirmed diagnosis of ms according to the mcdonald criteria, physician-administered expanded disability status scale (edss) range of 1-3.5, having regular menstrual cycle (between 21-35 days), and cognitive levels to give history and following the instructions. exclusion criteria: the exclusion criteria were: patients with acute attacks and using corticosteroid (three months prior to the study), taking oral contraceptive agents, and history of orthopedic lower extremity problems or other neurological disorders.

Keywords: multiple sclerosis menstrual cycle proprioception postural balance pain fatigue anxiety
to evaluate the blood levels and safety of iv and subcutaneous cdp6038 in subjects with rheumatoid arthritis using methotrexate

Conditions: Arthritis; Rheumatoid Arthritis

Summary: the primary objectives are to determine the relationship between blood levels of cdp6038 and suppression of c-reactive protein (crp) following single doses given as intravenous (iv) infusion or subcutaneous (sc) injection to rheumatoid arthritis (ra) patients. the safety of cdp6038 will also be evaluated.

the secondary objectives of the study include determination of the absolute bioavailability of cdp6038 given via sc administration compared with iv infusion; assessment of the immunogenicity potential of single dose cdp6038 and assessment, on an exploratory basis, of other relevant systemic biomarkers and changes in clinical response.

Eligibility criteria:
inclusion criteria: * ra \> 6 months duration on stable methotrexate * ≤9 swollen and ≤9 tender joints (28 joint count) * minimum screening crp of 0.5mg/l exclusion criteria: * participation in previous studies with defined agents and durations * previous treatment with defined agents and durations * presence of, or history of defined medical conditions including those particularly associated with deficiency in immune response * pregnancy * positive tests/signs of possible latent/active tuberculosis * positive hiv * drug addiction or alcohol abuse

Keywords: cdp6038
goserline acetate vs dienogest in endometriosi

Conditions: Endometriosis

Summary: clinical trial aims to evaluate efficacy of dienogest (dng) in comparison to goserline acetate in complete 12 week treatment of pain in women suffer from chronic pelvic pain diagnosed as endometriosis by laparoscopy and histopathology.

the study will be a clinical trial study of 12-week trial of gnrh (zoladex 3.75mg) injection once every 4 weeks and visanne (dienogest 2mg) oral once daily for 12 weeks in patients confirmed endometriosis by laparoscopic surgery. pretreatment assessment, the patients will be questioned about their pelvic symptoms (dysmenorrhea, nonmenstrual pelvic pain, and deep dyspareunia) after taking full history and examination , the study will investigate and evaluate possible early, long side effects and efficacy of treatment to controlling the pain.

Eligibility criteria:
inclusion criteria: * non pregnant women confirmed to have endometriosis by histopathology and not received any hormonal treatment yet. also, medical treatment was the proper choice for treatment of each case. exclusion criteria: * women suspect pregnancy. * breast feeding women. * previous use of hormonal agents (progestin less than 6 months, danazol less than 3 month, oral contraceptive pills less than 1 month before screening). * women with other gynecological pathology interfere with treatment we will use. * using of corticosteroids. * family history of osteoporosis.